XIENCE Skypoint™ 1804350-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 08717648233425), received between Feb 19, 2021 and May 21, 2026 — classified as 2 deaths, 15 injuries, 35 malfunctions.

The most frequently reported specific device problem is “Difficult to Remove” (19 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT, WITH A HISTORY OF CORONARY ARTERY DISEASE WAS ADMITTED WITH AN ST ELEVATION MYOCARDIAL INFARCTION (STEMI) INVOLVING THE CORONARY ARTERY OF THE ANTERIOR WALL. ONE XIENCE SKYPOINT (3.5 X 28 MM) STENT IMPLANTED. ON (B)(6) 2026, THE PATIENT WAS RE-ADMITTED WITH CHRONIC ISCHEMIC HEART DISEASE (A PRE-EXISTING CONDITION) AND OCCLUSION (STENOSIS) OF THE CORONARY ARTERY STENT. PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY WAS PERFORMED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE SAME DAY, (B)(6) 2026 TO A SHORT-TERM NURSING FACILITY. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Obstruction/Occlusion

  MAUDE report 25246472 ↗
• InjuryMay 21, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2026, THE PATIENT, WITH A HISTORY OF CORONARY ARTERY DISEASE AND CORONARY ARTERY STENOSIS, HAD THREE XIENCE SKYPOINT (2.5X18, 2.75X23, 3.5X28 MM) STENTS IMPLANTED. THE PATIENT WAS RE-ADMITTED ON (B)(6) 2026 WITH CHRONIC ISCHEMIC HEART DISEASE AND NON-ST ELEVATION MYOCARDIAL INFARCTION. PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY WAS PERFORMED WITH STENT PLACEMENT ON (B)(6) 2026. THE PATIENT WAS DISCHARGED ON (B)(6) 2026. ON (B)(6) 2026, THE PATIENT WAS RE-ADMITTED WITH DYSPNEA. NO TREATMENT WAS REPORTED AND THE PATIENT WAS DISCHARGED ON 01/16/2026. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Dyspnea; Myocardial Infarction; Obstruction/Occlusion

  MAUDE report 25243701 ↗
• MalfunctionJan 16, 2026Difficult to Remove; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE 3.5X28 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS GOING TO BE PUT ONTO THE GUIDE WIRE BUT IT WAS NOTED THAT THE STENT WAS NOT ON THE DELIVERY SYSTEM. THE STENT WAS FOUND ON THE WIRE IN THE PROTECTIVE SHEATH WHICH WAS DIFFICULT TO REMOVE. THERE WERE NO PATIENT INVOLVEMENT AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NEW SAME SIZE XIENCE SKYPOINT SDS WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24101277 ↗
• MalfunctionNov 20, 2025Failure to Advance; Difficult to Advance; Device Dislodged or Dislocated; Failure to Advance; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LESION IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 3.50X28MM RX XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITH THE AID OF A GUIDE LINER; HOWEVER THE SDS COULD NOT REACH THE TARGET LESION AS IT WAS THOUGHT THE STENT INTERACTED WITH SOME CALCIUM, A STENT STRUT OF THE PREVIOUSLY IMPLANTED STENT OR SOMETHING IN THE GUIDE LINER THEREFORE THE STENT DISLODGED FROM THE BALLOON AND REMAINED IN THE GUIDE LINER. THE GUIDE LINER WAS REMOVED WITH THE DISLODGED STENT INSIDE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606324 ↗
• MalfunctionOct 27, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE PERFORMED WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED, MILDLY TORTUOUS RIGHT CORONARY ARTERY THAT IS 50% STENOSED. AFTER ROTATIONAL ATHERECTOMY, A 3.50X28MM XIENCE SKYPOINT DRUG-ELUTING STENT WAS DEPLOYED AT 14 ATMOSPHERES (ATM) DURING THE FIRST INFLATION. THE DELIVERY BALLOON WAS SLIGHTLY PULLED BACK TO BE REINFLATED TO14 ATM; HOWEVER THE BALLOON RUPTURED AROUND 8 TO 10 ATM. THE DELIVERY BALLOON WAS REMOVED AND POST-DILATION WAS PERFORMED WITH AN UNSPECIFIED 3.5MM NON-COMPLIANT BALLOON COMPLETING THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23394573 ↗
• MalfunctionOct 27, 2025Improper or Incorrect Procedure or Method; Material Deformation; Activation Failure; Improper or Incorrect Procedure or Method; Material Deformation; Activation Failure

  T WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY TORTUOUS, MODERATELY CALCIFIED RIGHT CORONARY ARTERY. THE VESSEL WAS PREDILATED WITH A 2.5X15MM NON-ABBOTT BALLOON. THE 3.5X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM WAS OPENED, REMOVED FROM PACKAGING AND A SLIGHT FLARE WAS ALREADY OBSERVED ON THE PROXIMAL SIDE OF THE STENT. THE 3.5X28MM XIENCE SKYPOINT WAS INSERTED AND ATTEMPTED TO BE ADVANCED; HOWEVER, RESISTANCE WAS FELT AND THE STENT WAS NOT DEPLOYED. A NEW 3.5X28MM XIENCE SKYPOINT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23393859 ↗
• MalfunctionSep 9, 2025Material Rupture; Difficult to Advance; Material Rupture; Difficult to Advance

  IT WAS REPORTED THAT PROCEDURE WAS TO TREAT A DE NOVO, HEAVILY CALCIFIED MODERATELY TORTUOUS MID AND DISTAL RIGHT CORONARY ARTERY (RCA)LESION WITH 90% STENOSIS. A 3.50 X 28MM XIENCE SKYPOINT DES WAS PREPARED ACCORDING TO THE INSTRUCTIONS FOR USE. PRE-DILATION WAS CONDUCTED SEVERAL TIMES USING A WOLVERINE 3.0X15 MM BALLOON. ALTHOUGH SOME RESISTANCE WAS FELT WHILE PASSING THROUGH THE CALCIFIED LESION, THE DES SUCCESSFULLY CROSSED THE LESION AND WAS EXPANDED. HOWEVER, DURING THE INITIAL INFLATION AT APPROXIMATELY 6 ATMOSPHERES, A BALLOON RUPTURE OCCURRED. SINCE THE DES STENT REMAINED MOUNTED AND THE SYSTEM WAS RETRIEVED WITHOUT ISSUE, NO COMPLICATIONS AROSE. ADDITIONAL DILATIONS WERE PERFORMED SEVERAL TIMES USING A TASUKI 3.5X15 MM BALLOON. THE PROCEDURE WAS COMPLETED WITH ANOTHER 3.0X28MM XIENCE SKYPOINT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23009164 ↗
• MalfunctionMay 20, 2025Material Rupture; Material Rupture

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 75% STENOSIS, MILD CALCIFICATION AND MODERATE TORTUOSITY. THE 3.5X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED WITHOUT RESISTANCE; HOWEVER, RUPTURED UPON INFLATION AT NOMINAL PRESSURE. THE STENT REMAINED ON THE BALLOON WHEN THE SDS WAS REMOVED. A NON-ABBOTT STENT WAS USED TO CONTINUE AND COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22053727 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING A PROCEDURE TO TREAT THE MID LEFT ANTERIOR DESCENDING (MLAD) ARTERY WITH MILD TORTUOSITY. THE 3.5X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION AND THE STENT WAS IMPLANTED; HOWEVER, UNDER ANGIOGRAPHY A FREE EXTRAVASATION PERFORATION WAS NOTED. THEREFORE, PERICARDIAL SYNTHESIS WAS PERFORMED AND A 2.8X16MM GRAFTMASTER COVERED STENT WAS IMPLANTED AT 15 ATMOSPHERES (ATM) TO TREAT THE PERFORATION. THE PERFORATION WAS SEALED WITHOUT ISSUE. A 2.5X12MM XIENCE SKYPOINT STENT WAS IMPLANTED DISTAL TO THE GRAFTMASTER STENT AS A CONTINUATION OF THE PROCEDURE. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Perforation of Vessels

  MAUDE report 21943184 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE LEFT MAIN (LM) AND LEFT CIRCUMFLEX (LCX) CORONARY ARTERIES. THE LEFT ANTERIOR DESCENDING (LAD) CORONARY ARTERY WAS ACCESSED WITH A BLANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE AND PRE-DILATED WITH 2.5X12 MM COMPLIANT BALLOON, 3.0X15 MM NC BALLOON AND A 3.0X15 MM NON-ABBOTT BALLOON. UNDEREXPANSION WAS NOTED SO A 3.5X12 MM NON-ABBOTT BALLOON WAS USED FOR INTRAVASCULAR LITHOTRIPSY. AGAIN THE LESION WAS PRE-DILATED WITH A 3.5X12 MM NC BALLOON AND THE 3.5X28 MM XIENCE SKYPOINT STENT WAS DEPLOYED IN THE LEFT MAIN. POST-DILATATION WAS PERFORMED WITH 3.5X12 MM AND 4.5X12 MM NC BALLOONS. NEXT THE LCX WAS ACCESSED WITH A NON-ABBOTT WIRE AND A 3.0X15 MM NC BALLOON WAS USED TO PRE-DILATE THE LESION AND AFTER INITIAL KISSING BALLOON TECHNIQUE, THE 3.0X18 MM XIENCE SKYPOINT STENT WAS IMPLANTED FROM THE LEFT MAIN INTO THE LCX, LAYERED WITH THE PREVIOUSLY IMPLANTED 3.5X28 MM XIENCE SKYPOINT STENT. THE PROXIMAL OPTIMIZATION TECHNIQUE (POT) WAS PERFORMED WITH A 4.5X8 MM NC BALLOON AND KISSING BALLOON WAS PERFORMED WITH 3.5X12 MM NC IN THE LAD AND 3.0X12 MM NC IN THE LCX. AT THIS POINT THE ACTIVATED CLOTTING TIME (ACT) CAME BACK SUBTHERAPEUTIC AND ADDIT

  Patient problems: Cardiac Arrest; Hypoxia; Ischemia; Low Blood Pressure/ Hypotension; Nausea; Non specific EKG/ECG Changes; Respiratory Failure; Thrombosis/Thrombus; Ventricular Fibrillation

  MAUDE report 20738501 ↗
• MalfunctionNov 15, 2024Break; Failure to Advance; Material Deformation; Break; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE RIGHT CORONARY ARTERY (RCA) WITH NO CALCIFICATION OR TORTUOSITY. THE 3.5X28 MM XIENCE SKYPOINT STENT STRUTS BECAME BROKEN DURING THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20698820 ↗
• MalfunctionSep 18, 2024Failure to Advance; Contamination /Decontamination Problem; Failure to Advance; Contamination /Decontamination Problem

  IT WAS REPORTED THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY. THE 3.5X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS THE TARGET LESION DUE TO THE ANATOMY; THEREFORE, THE SDS WAS REMOVED FROM THE PATIENT AND IT WAS NOTED THAT THERE WERE FRAYED STRINGS ON/UNDER THE STENT THAT APPEARED TO RESEMBLE CLEAR PLASTIC. ANOTHER XIENCE SKYPOINT STENT WAS USED TO CONTINUE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20247207 ↗
• MalfunctionJun 17, 2024Material Rupture; Activation Failure; Material Rupture; Activation Failure

  IT WAS REPORTED THAT THE PROCEDURE WAS TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS PROXIMAL LEFT ANTERIOR DESCENDING ARTERY THAT IS 90% STENOSED. ROTABLATIONS WERE PERFORMED AND 3.0X15MM BALLOON WAS USED TO PRE-DILATE THE VESSEL SEVERAL TIMES. A 3.5X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM RUPTURED AT 6 ATMOSPHERES. NEGATIVE PRESSURE WAS APPLIED RIGHT AFTER AND DEVICE WAS REMOVED. IT WAS NOTED THE STENT REMAINED ON THE DEVICE AND FAILED TO DEPLOY. A 3.25X12MM NC TREK NEO WAS USED TO DILATE THE LESION AND A NEW 3.25X28MM XIENCE SKYPOINT WAS IMPLANTED. A 2.5X15MM NON-ABBOTT BALLOON WAS USED TO POST-DILATATE THE STENT. THERE WAS NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19547565 ↗
• MalfunctionJun 13, 2024Inflation Problem; Leak/Splash; Activation Failure; Inflation Problem; Leak/Splash; Activation Failure

  IT WAS REPORTED THAT THE 3.50X28 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION, HOWEVER THE BALLOON FAILED TO INFLATE, AND THE STENT DID NOT DEPLOY. THE SDS WAS REMOVED WITHOUT ISSUE. ONCE OUTSIDE OF THE ANATOMY, A LEAK WAS OBSERVED COMING FROM THE SHAFT. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. A NEW SAME SIZE SKYPOINT SDS WAS USED TO COMPLETE THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19534318 ↗
• MalfunctionJun 11, 2024Difficult to Advance; Device Dislodged or Dislocated; Material Deformation; Difficult to Advance; Device Dislodged or Dislocated; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY (MRCA) WITH MODERATE CALCIFICATION AND MORE TORTUOSITY. THE 3.5X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS BEING ADVANCED REPEATEDLY BEING PUSHED AND PULLED AROUND THE GUIDE CATHETER WHEN THE STENT BECAME DEFORMED DUE TO INTERACTION WITH THE EDGE OF THE GUIDE CATHETER. THE STENT DISLODGED AND THE PHYSICIAN APPROACHED FROM THE FEMORAL ARTERY USING THE SAME SDS RETRIEVING THE STENT. THE STENT WAS REMOVED AS A SINGLE UNIT WITH THE SDS. ANOTHER 3.5X28MM NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19512447 ↗
• InjuryMay 8, 2024Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A HEAVILY CALCIFIED AND TORTUOUS LESION IN THE RIGHT CORONARY ARTERY (RCA). THE LESION WAS PRE-TREATED WITH ATHERECTOMY. A 3.5X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE TARGET LESION; HOWEVER RESISTANCE WAS MET CROSSING THE LESION. WHEN POSITIONING THE STENT, THE STENT DISLODGED IN THE TARGET LESION. A 3.5X15MM AND A 3.5X18MM XIENCE SKYPOINT WERE USED TO COMPRESS THE STENT AGAINST THE LESION. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 19267943 ↗
• MalfunctionJan 24, 2024

  ELDERLY MALE WITH ACUTE ONSET OF SHORTNESS OF BREATH. PROCEDURE: PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY. WHEN THE ABBOTT XIENCE SKYPOINT WAS REMOVED FROM THE BOX/PACKAGE- TUBING WAS KINKED AND NOT ABLE TO BE USED ON PATIENT. MANUFACTURER RESPONSE FOR CORONARY DRUG-ELUTING STENT, XIENCE SKYPOINT (PER SITE REPORTER): WILL OBTAIN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18569036 ↗
• MalfunctionDec 15, 2023Material Separation; Difficult to Advance; Material Separation; Difficult to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED LEFT ANTERIOR DESCENDING ARTERY (LAD) LESION. A 3.50X 28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS USED WITH A DUAL ROTATING HEMOSTASIS VALUE (RHV); HOWEVER, RESISTANCE WAS MET AND TOO MUCH FORCE AT AN ANGLE WAS APPLIED. THE SDS SNAPPED INTO TWO PIECES AT THE PROXIMAL SHAFT. THE LOCATION OF THE SEPARATION WAS OUTSIDE THE ANATOMY; THEREFORE, THE SDS WAS SIMPLY REMOVED FROM THE PATIENT WITH NO ISSUES. ANOTHER XIENCE SKYPOINT WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18339402 ↗
• MalfunctionNov 3, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE MID CIRCUMFLEX WITH MILD TORTUOSITY AND NO CALCIFICATION. THE 3.5X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS INSPECTED AND PREPARED PER INSTRUCTIONS FOR USE (IFU). THE SDS WAS LOADED ONTO THE GUIDE WIRE ADVANCING TO THE TARGET LESION WITHOUT RESISTANCE WHEN IT WAS REALIZED THAT THE STENT WAS MISSING. FLUOROSCOPY SHOWED NO STENT WAS IN THE ANATOMY AND THE PHYSICIAN THINKS THE STENT DISLODGED PRIOR TO LOADING ONTO THE GUIDE WIRE. THE STENT WAS NOT FOUND ON THE TABLE OR THE FLOOR. ANOTHER 3.5X38MM XIENCE SKYPOINT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. SUBSEQUENT TO THE INITIALLY FILED REPORT, IT WAS FOUND DURING DEVICE ANALYSIS THAT THE DEVICE HAD BEEN INFLATED. THE ACCOUNT CONFIRMED THE DEVICE WAS INFLATED WHEN IT REACHED THE LESION AND THAT IS WHEN IT WAS NOTED THAT THE STENT WAS NOT ON THE BALLOON. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18066057 ↗
• MalfunctionSep 25, 2023Difficult to Remove; Failure to Advance; Difficult to Remove; Failure to Advance

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A MILDLY TORTUOUS MID RIGHT CORONARY ARTERY THAT IS 90% STENOSED. THE 3.5X028MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) FAILED TO CROSS DUE TO ANATOMY. DURING REMOVAL RESISTANCE WAS MET WITH ANATOMY. ANOTHER NON-ABBOTT STENT WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO ADVERSE PATIENT EFFECT AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17814271 ↗
• InjurySep 20, 2023Difficult to Advance; Device Dislodged or Dislocated; Difficult to Advance; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A HEAVILY CALCIFIED, MODERATELY TORTUOUS RIGHT CORONARY ARTERY. THE 3.5X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCING TO THE LESION WITH AID OF AN GUIDELINER AND MET RESISTANCE DUE TO THE HEAVILY CALCIFICATION. THE SDS WAS ADVANCED; HOWEVER, NEEDED TO BE RETRACTED A BIT TO OVERLAP WITH A PREVIOUSLY IMPLANT MID SEGMENT STENT. THE SDS WAS RETRACTED TOO FAR PROXIMALLY AND WHEN ATTEMPTING TO ADVANCE THE STENT DISLODGED. A 3.5MM TREK BALLOON DILATATION CATHETER WAS ADVANCED INTO THE STENT SUCCESSFULLY AND USED TO DEPLOY THE STENT INTO THE VESSEL WALL. NO OTHER DEVICE WAS USED. THERE WAS NO ADVERSE PATIENT SEQUELA AND CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17785185 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A STAGED PROCEDURE WAS PERFORMED ON (B)(6) 2022, TREATING A TARGET LESION IN THE BIFURCATION OF THE LEFT MAIN AND PROXIMAL TO MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 3.5 X 28 MM XIENCE SKYPOINT STENT AND A 3.25 X 28 MM XIENCE SKYPOINT STENT WERE IMPLANTED, FOLLOWED BY BALLOON DILATATION VIA KISSING BALLOON TECHNIQUE AT THE BIFURCATION. ON (B)(6) 2023, THE PATIENT WAS RE-HOSPITALIZED WITH RESTENOSIS NOTED IN THE 3.5 X 28 MM XIENCE SKYPOINT STENT. ADDITIONAL INTERVENTION WAS PERFORMED, WITH IMPLANT OF DRUG ELUTING STENTS. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Stenosis

  MAUDE report 17746541 ↗
• MalfunctionSep 13, 2023Difficult to Remove; Improper or Incorrect Procedure or Method; Difficult to Remove; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT THE MID CIRCUMFLEX CORONARY ARTERY WITH HEAVILY CALCIFIED PLAQUE AND TORTUOUS ANATOMY. PRE-DILATATION WAS NOT PERFORMED AND A NON-ABBOTT GUIDE EXTENSION CATHETER WAS USED. THE 3.5X28 MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS ADVANCED TO THE LESION AND WAS PULLED WITH FORCE, CAUSING THE SDS TO BECOME STUCK WITH THE NON-ABBOTT GUIDE EXTENSION CATHETER. THE SDS WAS REMOVED AS A SINGLE UNIT. PRE-DILATATION WAS THEN PERFORMED WITH A TREK BALLOON AND ANOTHER XIENCE STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17739305 ↗
• MalfunctionAug 21, 2023Difficult to Remove; Failure to Advance; Material Deformation; Difficult to Remove; Failure to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE LEFT ANTERIOR DESCENDING (LAD) ARTERY WITH 99% STENOSIS AND MILD TORTUOSITY. THE 3.5X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) HAD RESISTANCE DURING ADVANCEMENT WITH THE ANATOMY AND FAILED TO CROSS. THERE WAS RESISTANCE WITH THE ANATOMY UPON REMOVAL BUT WAS REMOVED INDEPENDENTLY. THE EDGE OF THE STENT WAS NOTED TO BE BENT. THERE WAS NO ADVERSE PATIENT EFFECT AND THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17584448 ↗
• MalfunctionJul 11, 2023Difficult to Remove; Difficult to Advance; Material Deformation; Difficult to Remove; Difficult to Advance; Material Deformation

  IT WAS REPORTED THAT THE PROCEDURE WAS PERFORMED TO TREAT A LESION IN THE MID RIGHT CORONARY ARTERY (MRCA) WITH MODERATE CALCIFICATION, MODERATE TORTUOSITY AND 90% STENOSIS. AFTER PRE DILATING THE LESION WITH AN UNSPECIFIED BALLOON, THE 3.50X28MM XIENCE SKYPOINT STENT DELIVERY SYSTEM (SDS) WAS INTRODUCED WITH A NON-ABBOTT GUIDE EXTENSION CATHETER AND CROSSED THE LESION; HOWEVER, THE STENT BECAME STUCK WITH THE GUIDE EXTENSION AND MET RESISTANCE DURING ADVANCEMENT AND REMOVAL. AFTER REMOVAL, THE STENT EDGE WAS NOTED FLARED. ANOTHER NON-ABBOTT STENT WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17302081 ↗